FDA.reportPublic FDA data

Needle

Primary DI
20841268107018
Brand
Needle
Company
GALT MEDICAL CORP.
Model
NDL-109-01
Catalog number
NDL-109-01
Device description
Needle
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268107011PackageGS15In Commercial Distribution
20841268107018PackageGS150In Commercial Distribution
00841268107014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810701110841268107011
2084126810701820841268107018
00841268107014008412681070148412681070140841268107014

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customerservice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268100855GuidewireSGW-019-38SGW-019-382017-07-03
00841268100862GuidewireSGW-019-40SGW-019-402017-07-03
00841268100879GuidewireSGW-019-41SGW-019-412017-07-03
00841268100886GuidewireSGW-019-52SGW-019-522017-07-03
00841268100893GuidewireSGW-019-53SGW-019-532017-07-03
00841268100909GuidewireSGW-021-02SGW-021-022017-07-03
00841268100916GuidewireSGW-021-03SGW-021-032017-07-03
00841268100923GuidewireSGW-021-04SGW-021-042017-07-03
00841268100930GuidewireSGW-022-09SGW-022-092017-07-03
00841268100947GuidewireSGW-022-10SGW-022-102017-07-03
00841268100954GuidewireSGW-022-11SGW-022-112017-07-03
00841268100961GuidewireSGW-022-13SGW-022-132017-07-03
00841268100978GuidewireSGW-022-14SGW-022-142017-07-03
00841268100985GuidewireSGW-022-15SGW-022-152017-07-03
00841268100992GuidewireSGW-022-16SGW-022-162017-07-03
00841268101005GuidewireSGW-022-32SGW-022-322017-07-03
00841268101012GuidewireSGW-022-33SGW-022-332017-07-03
00841268101029GuidewireSGW-022-36SGW-022-362017-07-03
00841268101036Guidewire SGW-022-49SGW-022-492017-07-03
00841268101043GuidewireSGW-035-00SGW-035-002017-07-03

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Primary DI, Brand, Company table
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00846159039900SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
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00846159039924SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
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